A Study to Investigate the Effect of SFF on Glucose and Insulin Responses

Not Applicable

Completed

• Conditions: Postprandial Glycemic Response
• Interventions: Dietary Supplement: Glucose; Dietary Supplement: Regular chocolate chips; Dietary Supplement: SFF chocolate chips; Dietary Supplement: SFF

• Registration Number: NCT05587426
• Lead Sponsor: Cambridge Glycoscience

Brief Summary

This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of:

1. Sugars from Fiber in comparison with dextrose

2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-03
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Individuals, 20-65 years of age, inclusive.
2. Body mass index (BMI) between 19 and 35 kg/m², inclusive, at screening.
3. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
4. Willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial.
5. Willing to avoid the consumption of alcohol, unusual food intake, and unusual physical activity 24h prior to each study visit. Failure to follow will result in rescheduled visit.
6. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator.

Exclusion Criteria

1. Failure to meet any one of the inclusion criteria.
2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
4. Major trauma or surgical event within 3 months of screening.
5. Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines.
6. Known intolerance, sensitivity or allergy to test foods.
7. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
8. History of cancer in the prior two years, except for non-melanoma skin cancer.
9. Exposure to any non-registered drug product within 30 d prior to screening.
10. Self-reported pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose - Control	Glucose	20 g of glucose mixed with 250 ml of cold water
Regular chocolate chips - Control	Regular chocolate chips	50 g of regular chocolate chips
SFF chocolate chips	SFF chocolate chips	50 g of SFF chocolate chips
SFF	SFF	20 g of SFF mixed with 250 ml of cold water

Primary Outcome Measures

Name	Time	Method
Plasma glucose iAUC (T0 - T120min) after test meals	Through intervention periods of two hours	Compare the postprandial glucose incremental area under the curve after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips

Secondary Outcome Measures

Name	Time	Method
Serum insulin iAUC (T0 - T120min) and each time point after test meals	Through intervention periods of two hours	Compare the postprandial insulin levels at each time and incremental area under the curve after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips
Plasma glucose at each time point after test meals	Through intervention periods of two hours	Compare the postprandial glucose levels at each time point after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips

Trial Locations

Locations (1)

INQUIS Clinical Research, Ltd; 🇨🇦 Toronto, Ontario, Canada